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# Tagrisso Phase 3 Data in Lung Cancer
- URL: https://www.fdaweb.com/tagrisso-phase-3-data-in-lung-cancer/
- Published: 2023-09-11T12:00:00.000Z
- Updated: 2026-09-14T18:55:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155291

AstraZeneca says data from its FLAURA2 Phase 3 trial showed that Tagrisso (osimertinib) plus chemotherapy extended median progression-free survival by nearly nine months compared to Tagrisso alone for patients with locally advanced (Stage 3B-3C) or metastatic (Stage 4) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Results showed Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone, it says.

The drug was approved in 2015 for patients whose tumors with EGFR mutation (T790M) and whose disease has progressed after treatment with other EGFR-blocking therapies. In 2018, expanded approval was granted for the first-line treatment of growth factor receptor EGFR mutations exon 19 deletions or exon 21 L858R.

AstraZeneca notes that it has several ongoing Tagrisso Phase 3 trials focused on earlier stages of lung cancer, including a trial in the Stage 1A2-1A3 adjuvant resectable setting (ADAURA2), and in the Stage 3 locally advanced unresectable setting (LAURA). It is also studying ways to address tumor mechanisms of resistance through the SAVANNAH and ORCHARD Phase 2 trials, and the SAFFRON Phase 3 trial.